Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Preterm birth <35 weeks
研究概览
简要总结
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth
详细描述
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 year old or older
- •Singleton pregnancy
- •No prior SPTB or second trimester losses between 160 and 366 weeks
- •TVU CL ≤25mm between 180 and 236 weeks
排除标准
- •Multiple pregnancy
- •Prior SPTB or second trimester losses between 160 and 366 weeks
- •Cerclage in situ
- •Painful regular uterine contraction and/or preterm labor
- •Rupture membranes
- •Major fetal anomaly or aneuploidy
- •Active vaginal bleeding
- •Placenta previa and/or accreta
- •Cervical dilation >1.0 cm and/or visible membranes by pelvic exam
- •Suspicion of chorioamnionitis
研究组 & 干预措施
Cerclage
Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
干预措施: Cervical cerclage (Procedure)
Cerclage
Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
干预措施: Vaginal progesterone (Drug)
Control
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
干预措施: Vaginal progesterone (Drug)
结局指标
主要结局
Preterm birth <35 weeks
时间窗: At delivery
Incidence of spontaneous preterm birth less than 35 weeks
次要结局
- Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks(At delivery)
- Histologically proven clinical chorioamnionitis(At delivery)
- Neonatal outcomes: low birth weight (<2500g),(At delivery)
- Neonatal outcomes: admission to intensive care nursery(At delivery)
- Neonatal outcomes: IVH grade 3 or 4(at least 30 days after delivery, up to 6 months after delivery)
- Neonatal outcomes: retinopathy of prematurity(at least 30 days after delivery, up to 6 months after delivery)
- Neonatal outcomes: respiratory distress syndrome(at least 30 days after delivery, up to 6 months after delivery)
- Neonatal outcomes: birth weight(At delivery)
- Neonatal outcomes: bronchopulmonary dysplasia(at least 30 days after delivery, up to 6 months after delivery)
- Neonatal outcomes: length of neonatal hospital admission(at least 30 days after delivery, up to 6 months after delivery)
- Neonatal outcomes: neonatal mortality(28 days after delivery)
- Mean gestational age at delivery(At delivery)